Method for treating osteoarthritis pain by administering resiniferatoxin

Abstract

Disclosed herein are methods of administering resiniferatoxin (RTX) for treatment of osteoarthritis (OA) pain, and compositions for use in such methods.

What is claimed is: 
     
       1. A method for treating osteoarthritis (OA) pain comprising administering a therapeutically effective amount of resiniferatoxin (RTX) to a human subject in need thereof, wherein the administering is by an intra-articular injection to an affected joint; and wherein the composition is a pharmaceutical formulation comprising RTX and a pharmaceutically acceptable carrier at a concentration of 1 μg/mL to 50 μg/mL. 
     
     
       2. The method of  claim 1 , wherein the dose of RTX is from about 1 μg to about 100 μg. 
     
     
       3. The method of  claim 2 , wherein the dose of RTX is from about 5 μg to about 40 μg. 
     
     
       4. The method of  claim 2 , wherein the dose of RTX is about 12.5 μg. 
     
     
       5. The method of  claim 2 , wherein the dose of RTX is about 20 μg. 
     
     
       6. The method of  claim 1 , wherein the dose of RTX is about 5 μg, 12.5 μg, 20 μg or 30 μg, optionally wherein the dose is in a volume of about 2.5 ml to about 15 ml. 
     
     
       7. The method of  claim 1 , wherein the affected joint is a knee joint, a hip joint, a hand joint, a shoulder joint, an ankle joint, a foot joint, an elbow joint, a wrist joint, a sacroiliac joint, or a spine joint, or combinations thereof. 
     
     
       8. The method of  claim 1 , wherein the affected joint is a large joint. 
     
     
       9. The method of  claim 1 , wherein the RTX is administered to a single site. 
     
     
       10. The method of  claim 1 , wherein the RTX is administered to a plurality of sites. 
     
     
       11. The method of  claim 1 , wherein the pharmaceutically acceptable carrier comprises polysorbate 80, or wherein the pharmaceutically acceptable carrier comprises polyethylene glycol, or wherein the pharmaceutically acceptable carrier comprises a sugar or sugar alcohol or wherein the pharmaceutically acceptable carrier comprises a pharmaceutically acceptable buffer. 
     
     
       12. The method of  claim 1 , wherein the pharmaceutical formulation has a pH in the range of 6 to 7.6. 
     
     
       13. The method of  claim 1 , wherein the pharmaceutically acceptable carrier comprises a pharmaceutically acceptable salt. 
     
     
       14. The method of  claim 1 , wherein RTX is administered at least one time per year. 
     
     
       15. The method of  claim 14 , wherein the administration occurs within a time period of from about 1 week to about 12 months or more. 
     
     
       16. The method of  claim 1 , wherein the dose of RTX ranges from 0.1-1 μg, 1-2 μg, 2-5 μg, 5-10 μg, 10-20 μg, 20-30 μg, 30-40 μg, 40-50 μg, 50-60 μg, 60-70 μg, 70-80 μg, 80-90 μg, or 90-100 μg. 
     
     
       17. The method of  claim 2 , wherein the dose of RTX is from about 10 μg to about 30 μg. 
     
     
       18. The method of  claim 2 , wherein the dose of RTX is from about 15 μg to about 25 μg.